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Fluid path - connectors

BioEndCap

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Overview

BioEndCap™ End caps with pull tab

BioEndCap is designed to terminate a disposable manifold until an in-process new sterile connection is to be made. Produced from DMF listed polypropylene compliant with FDA and USP Class VI and European Pharmacopoeia.

Features and benefits

  • Lot numbers moulded in for full traceability
  • Unique pull-tab ensures easy removal of the cap
  • Suitable for sterilisation by autoclave and gamma irradiation

Technical summary

Max. operating pressure4 bar
Max. operating pressure58 psi
Shelf life5 years
Certification and complianceADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
TC Size½-¾ TC - 1-1½ TC in

Technical Summary table lists features available within the range. See ‘Specifications’ tab for model specific information.

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Specifications

Technical specifications

BioEndCap
Max. operating pressure4 bar (58 psi) 
Fluid temperature5 °C to 40 °C (40 °F to 104 °F)  
Operating temperature-5 °C to 40 °C (23 °F to 104 °F)  
Autoclave stability121 °C 30 minutes 
Gamma stability50 kGy 
Shelf life5 years
Certification and complianceADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
TC Size½-¾ TC - 1-1½ TC in
Quantity10 PCS

Materials of construction

MaterialNatural PP

Validation

About the BioPure components validation guides

These components are manufactured and packed in an ISO 14644-1 Class 7 cleanroom from a DMF listed polypropylene compliant with FDA and USP VI. Product validation studies were performed on the post gamma irradiated BioPure components.

  • Evaluated for extractables using a multi-solvent approach to BPOG guidelines
  • USP Class VI compliant and Animal Derived Component Free (ACDF)
  • Raw material assigned FDA drug master number: DMF 9040 and fulfils requirements of European pharmacopoeia, 5th edition (2004) and supplement 5.8 (07/2007), monograph 3.2.2.
  • Suitable for sterilisation by autoclave and gamma irradiation
  • Lot traceability
  • Precision compression between tube and fittings eliminates flow bypass and media entrapment

Download summary guide

BioEndCap validation summary guide

Validation summary guide PDF - 379,5kb

Documentation

Brochures

  1. BioPure overview (EN).pdf
    PDF - 636,9kb

Datasheets

  1. BioEndCap datasheet (EN).pdf
    PDF - 178,5kb

Other Resources

  1. 1 inch - 1½ inch TC BioEndCap technical drawing.pdf
    PDF - 185,9kb
  2. ½ inch - ¾ inch TC BioEndCap technical drawing.pdf
    PDF - 240,6kb

Order Information

Product codes

BioEndCap product codes

Part Number Size Flange Size Material
PPEC05000750 1/2" - 3/4" TC 1/2" - 3/4" Natural PP
PPEC10001500 1" - 1 1/2" TC 1" - 1 1/2" Natural PP

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